Back to resultsANEUFIX for Endoleaks Type II (ACP-T5)
Primary Purpose
Abdominal Aortic Aneurysm
Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Aneufix ACP-T5
Sponsored by
About this trial
This is an interventional device feasibility trial for Abdominal Aortic Aneurysm focused on measuring AAA, Endoleak
Eligibility Criteria
Inclusion Criteria:
- Persistent type IIa or IIb endoleak (more than 6 months post-EVAR or post-embolization procedure); AND
- Volume of the 'endoleak void' can be determined upfront; AND
- An EVAR without circulatory complications; AND
- An endoleak confirmed by CT scan in preceding 6 weeks demonstrating the high likelihood of the isolated nature of the endoleak; AND
- An aneurysm sac growing in contours after EVAR (per European Guidelines) as documented in the preceding 6 weeks by means of echo (or alternative visualization technique); AND
- An aneurysm sac that can be punctured in translumbar approach ; AND
- Possibility to withhold anti-thrombogenic medication temporarily; AND
- Ability and willingness to undergo the translumbar procedure under local anesthesia in a CT scan; AND
- Be older than 18 years.
Exclusion Criteria:
- Patient not able or willing to give written Informed Consent; OR
- Patient undergoing emergency procedures; OR
- Patient with traumatic vascular injury; OR
- Patient with hemostatic disorder or who is clinically unstable; OR
- Patient with a too high risk of abdominal sac rupture to allow safe radiological and scanographic assessments; OR
- Patient who is allergic to contrast media or anticoagulants; OR
- Patient with renal impairment (serum creatinine > 2 mg/dl or > 176 mmol/l); OR
- Patient who is participating in another trial with an investigational drug or medical device; OR
- Women of child-bearing potential; OR
- Patient with a life expectancy of less than 12 months.
Sites / Locations
- Medisch Centrum Westeinde
- Spaarne Gasthuisberg
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Treatment
Arm Description
Aneufix ACP-T5
Outcomes
Primary Outcome Measures
Technical success of Type II endoleak repair with Aneufix ACP-T5 as demonstrated by the absence of an endoleak at the end of the procedure.
At the end of the injection procedure, the technical success will be determined by angiographic recording and physician assessment of absence of endoleak. CT scan at 24 hrs is obtained to reconfirm the absence of endoleak.
Secondary Outcome Measures
Clinical succes rate.
The clinical succes rate is defined as the absence of aneurysm sac growth after the procedure of ACP-T5 injection.
Safety aspects I : intra-operative complication rate.
Intra-operative occurrence of complications.
Safety aspects II: Peri-operative complication rate.
All complications as well as the occurrence of adverse events and adverse device effects during the period of 24 hrs - 1 month are observed, documented, adjudicated and reported. adverse device effects are observed, documented, adjudicated and reported.
Safety aspects III : Mid- and long-term complication rate.
All complications as well as the occurrence of adverse events and adverse device effects during the period of 1-12 months are observed, documented, adjudicated and reported. adverse device effects are observed, documented, adjudicated and reported.
Aneurysm sac rupture.
The aneurysm sac rupture rate is assessed over a period of 12 months.
Survival.
The survival rate throughout the study and up to 24 months is assessed.
Full Information
NCT ID
NCT02487290
First Posted
June 29, 2015
Last Updated
February 19, 2021
Sponsor
TripleMed B.V.
Collaborators
Fakkel bvba
1. Study Identification
Unique Protocol Identification Number
NCT02487290
Brief Title
ANEUFIX for Endoleaks Type II
Acronym
ACP-T5
Official Title
Feasibility Study of Treatment Type II Endoleaks With ACP-T5: a Novel Approach.
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
February 26, 2018 (Actual)
Primary Completion Date
February 1, 2019 (Actual)
Study Completion Date
December 15, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
TripleMed B.V.
Collaborators
Fakkel bvba
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The study is a non-randomized, multi-center safety and feasibility trial of Aneufix ACP-T5 to treat patients with Isolated type II endoleak in the presence of a non-shrinking AAA sac following an EVAR procedure.
Detailed Description
The investigational device is called Aneufix, more specifically the model ACP-T5, which is a product treating the endoleak by blockage of backflowing blood vessels, i.e. by filling the 'endoleak void and nidus of feeding artery and exit of existing draining arteries'.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Abdominal Aortic Aneurysm
Keywords
AAA, Endoleak
7. Study Design
Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
This is a feasibility study, where initially 5 patients are to be treated.
Masking
None (Open Label)
Allocation
N/A
Enrollment
4 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment
Arm Type
Experimental
Arm Description
Aneufix ACP-T5
Intervention Type
Device
Intervention Name(s)
Aneufix ACP-T5
Other Intervention Name(s)
ANEUFIX
Intervention Description
The ACP-T5 is injected via translumbar approach into the aneurysm sac near the entrance/exit of bloodvessel. ACP-T5 will cure and block the endoleak.
Primary Outcome Measure Information:
Title
Technical success of Type II endoleak repair with Aneufix ACP-T5 as demonstrated by the absence of an endoleak at the end of the procedure.
Description
At the end of the injection procedure, the technical success will be determined by angiographic recording and physician assessment of absence of endoleak. CT scan at 24 hrs is obtained to reconfirm the absence of endoleak.
Time Frame
24h
Secondary Outcome Measure Information:
Title
Clinical succes rate.
Description
The clinical succes rate is defined as the absence of aneurysm sac growth after the procedure of ACP-T5 injection.
Time Frame
6 and 12 months
Title
Safety aspects I : intra-operative complication rate.
Description
Intra-operative occurrence of complications.
Time Frame
All complications observed during the ACP-T5 injection procedure are documented.
Title
Safety aspects II: Peri-operative complication rate.
Description
All complications as well as the occurrence of adverse events and adverse device effects during the period of 24 hrs - 1 month are observed, documented, adjudicated and reported. adverse device effects are observed, documented, adjudicated and reported.
Time Frame
1 month
Title
Safety aspects III : Mid- and long-term complication rate.
Description
All complications as well as the occurrence of adverse events and adverse device effects during the period of 1-12 months are observed, documented, adjudicated and reported. adverse device effects are observed, documented, adjudicated and reported.
Time Frame
1-12 months
Title
Aneurysm sac rupture.
Description
The aneurysm sac rupture rate is assessed over a period of 12 months.
Time Frame
12 months
Title
Survival.
Description
The survival rate throughout the study and up to 24 months is assessed.
Time Frame
24 months.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Persistent type IIa or IIb endoleak (more than 6 months post-EVAR or post-embolization procedure); AND
Volume of the 'endoleak void' can be determined upfront; AND
An EVAR without circulatory complications; AND
An endoleak confirmed by CT scan in preceding 6 weeks demonstrating the high likelihood of the isolated nature of the endoleak; AND
An aneurysm sac growing in contours after EVAR (per European Guidelines) as documented in the preceding 6 weeks by means of echo (or alternative visualization technique); AND
An aneurysm sac that can be punctured in translumbar approach ; AND
Possibility to withhold anti-thrombogenic medication temporarily; AND
Ability and willingness to undergo the translumbar procedure under local anesthesia in a CT scan; AND
Be older than 18 years.
Exclusion Criteria:
Patient not able or willing to give written Informed Consent; OR
Patient undergoing emergency procedures; OR
Patient with traumatic vascular injury; OR
Patient with hemostatic disorder or who is clinically unstable; OR
Patient with a too high risk of abdominal sac rupture to allow safe radiological and scanographic assessments; OR
Patient who is allergic to contrast media or anticoagulants; OR
Patient with renal impairment (serum creatinine > 2 mg/dl or > 176 mmol/l); OR
Patient who is participating in another trial with an investigational drug or medical device; OR
Women of child-bearing potential; OR
Patient with a life expectancy of less than 12 months.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel Eefting, Dr
Organizational Affiliation
Medisch Centrum Westeinde Den Haag
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Erik Vermeulen, Dr
Organizational Affiliation
Spaarne Gasthuis, Haarlem
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medisch Centrum Westeinde
City
Den Haag
ZIP/Postal Code
2512
Country
Netherlands
Facility Name
Spaarne Gasthuisberg
City
Haarlem
ZIP/Postal Code
2035 RC
Country
Netherlands
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
There is currently no plan to share with other investigators then those participating in the study.
Learn more about this trial
ANEUFIX for Endoleaks Type II
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